Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT00973960
Status:
COMPLETED
Last Update Posted:
2011-08-08
First Post:
2009-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Trial of the EndoBarrier™ Flow Restrictor for Glycemic Improvement in Type 2 Diabetics
Sponsor:
Morphic Medical Inc.
Organization:
Study Overview
Official Title:
A Pilot Trial of the EndoBarrier™ Flow Restrictor for Glycemic Improvement in Type 2 Diabetics
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objective of the study is to demonstrate the safety and efficacy of the EndoBarrier Flow Restrictor in the glycemic control of diabetes in subjects with Type 2 diabetes.
The primary efficacy endpoint is an assessment of glycemic control at week 24 or last assessment measured via HbA1c.
The primary efficacy endpoint is an assessment of glycemic control at week 24 or last assessment measured via HbA1c.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: